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FDA 510(k)

BOSTON ES MULTIVISION (ENFLUFOCON A) CONTACT LENS

K-Number: K970698 · 1997-05-06

ApplicantPolymer Technology Corp.
Decision Date1997-05-06
Product CodeHQD
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

BOSTON ES MULTIVISION (ENFLUFOCON A) CONTACT LENS is the device name listed in this FDA 510(k) record. The listed applicant is Polymer Technology Corp.. It received FDA 510(k) clearance on 1997-05-06 under 510(k) number K970698. The device is classified under product code HQD. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BOSTON ES MULTIVISION (ENFLUFOCON A) CONTACT LENS?

BOSTON ES MULTIVISION (ENFLUFOCON A) CONTACT LENS is a medical device that received FDA 510(k) clearance on 1997-05-06. The listed applicant is Polymer Technology Corp.. The 510(k) number is K970698.

When did BOSTON ES MULTIVISION (ENFLUFOCON A) CONTACT LENS receive FDA 510(k) clearance?

BOSTON ES MULTIVISION (ENFLUFOCON A) CONTACT LENS received FDA 510(k) clearance on 1997-05-06, under 510(k) number K970698.

Who is the listed applicant for BOSTON ES MULTIVISION (ENFLUFOCON A) CONTACT LENS?

The FDA 510(k) record lists Polymer Technology Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BOSTON ES MULTIVISION (ENFLUFOCON A) CONTACT LENS?

The FDA product code for BOSTON ES MULTIVISION (ENFLUFOCON A) CONTACT LENS is HQD.

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Other records listing Polymer Technology Corp. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K011945RIGID GAS PERMEABLE CONTACT LENS SOLUTIONK980133BAUSCH & LOMB WETTING AND SOAKING SOLUTIONK974466BOSTON ADVANCE CLEANERK973217BOSTON LIQUID ENZYMATIC CLEANERK951552BOSTON CONTACT LENS CASEK943177BOSTON(R) 7 - 30(ENFLUFOCON A)

View all 23 devices →

Related Devices (Code: HQD)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K253822GPA (hexafocon A) Rigid Gas Permeable Contact LensesZhuhai Fitlens Medical Technology Co., Ltd.K242393Acuity 181™ (tisilfocon A) and Acuity 181™ (tisilfocon A) with Tangible™ Hydra-PEG® Rigid Gas Permeable Contact LensesAcuity Polymers, Inc.K241398SDJMASTERVISION (fluoroxyfocon A) Rigid Gas Permeable Contact LensesTianjin Mastervision Technology Co., Ltd.K241571BostonSight® Specialty LensesBoston Foundation For Sight, Inc. D/B/A BostonsightK240618Acuity 200™ (fluoroxyfocon A) Rigid Gas Permeable Contact Lens; Acuity 100™ (hexafocon A) Rigid Gas Permeable Contact Lens; Acuity 200™ with Tangible® Hydra-PEG® (fluoroxyfocon A) Rigid Gas Permeable Contact Lens; Acuity 100™ with Tangible® Hydra-PEG® (hexafocon A) Rigid Gas Permeable Contact LensAcuity Polymers, Inc.K233325Visionary Optics Scleral Contact Lens (roflufocon D, roflufocon E, hexafocon A, hexafocon B, tisilfocon A, fluoroxyfocon A)Visionary Optics, LLC

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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